K173119 is an FDA 510(k) clearance for the DRI OCT Triton. This device is classified as a Tomography, Optical Coherence (Class II - Special Controls, product code OBO).
Submitted by Topcon Corporation (Tokyo, JP). The FDA issued a Cleared decision on January 19, 2018, 112 days after receiving the submission on September 29, 2017.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.1570. Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases..
| 510(k) Number | K173119 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | September 29, 2017 |
| Decision Date | January 19, 2018 |
| Days to Decision | 112 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Summary PDF |
| Product Code | OBO - Tomography, Optical Coherence |
| Device Class | Class II - Special Controls |
| CFR Regulation | 21 CFR 886.1570 |
| Definition | Viewing, Imaging, Measurement, And Analysis Of Ocular Structures. Diagnostic Device To Aid In The Detection And Management Of Various Ocular Diseases. |